THE WOODLANDS, Texas,
May 31, 2016 /PRNewswire/
-- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today
announced that the U.S. Food and Drug Administration has accepted
for filing the New Drug Application for telotristat etiprate, an
oral drug for the treatment of carcinoid syndrome. The FDA
has granted a Priority Review of the NDA filing and set a
Prescription Drug User Fee Act ("PDUFA") target action date of
November 30, 2016.
"The granting of priority review by the FDA underscores the need
for improving the lives of the patients and caregivers who live
with carcinoid syndrome on a daily basis," said Lexicon President
and Chief Executive Officer, Lonnel
Coats. "If approved, telotristat etiprate would be the only
approved therapy for patients who are no longer able to control
their carcinoid syndrome with the current standard of care
alone."
Carcinoid syndrome is a rare disease affecting thousands of
cancer patients with metastatic neuroendocrine tumors (mNETs) that
have spread to the liver and other organs from the gastrointestinal
tract. The condition is characterized by frequent and
debilitating diarrhea that often prevents patients from leading
active, predictable lives, as well as facial flushing, abdominal
pain, fatigue and, over time, heart valve damage.
About Telotristat Etiprate
Discovered using Lexicon's unique approach to gene science,
telotristat etiprate is the first investigational drug in clinical
studies to target tryptophan hydroxylase, an enzyme that triggers
the excess serotonin production within mNET cells that leads to
carcinoid syndrome. While existing treatments for carcinoid
syndrome work to reduce the release of serotonin outside tumor
cells, telotristat etiprate works at the source to reduce serotonin
production within the tumor cells. By specifically inhibiting
serotonin production, telotristat etiprate seeks to control this
important driver of carcinoid syndrome and, in turn, provide
patients with more control over their disease.
Telotristat etiprate has received Fast Track and Orphan Drug
designation from the U.S. Food and Drug Administration.
Lexicon retains rights to market telotristat etiprate in the
U.S. and Japan, and is building
the in-house commercial infrastructure to serve the U.S. market.
Lexicon has a license and collaboration agreement with Ipsen to
commercialize telotristat etiprate in Europe and other countries outside the U.S.
and Japan.
About Lexicon
Lexicon is a fully integrated biopharmaceutical company that is
applying a unique approach to gene science based on Nobel
Prize-winning technology to discover and develop precise medicines
for patients with serious, chronic conditions. Through its
Genome5000™ program, Lexicon scientists have studied the role and
function of nearly 5,000 genes over the last 20 years and have
identified more than 100 protein targets with significant
therapeutic potential in a range of diseases. Through the precise
targeting of these proteins, Lexicon is pioneering the discovery
and development of innovative medicines to safely and effectively
treat disease. Lexicon has a pipeline of promising drug candidates
in clinical and pre-clinical development in oncology, diabetes and
metabolism. For additional information please visit
www.lexpharma.com.
Safe Harbor Statement
This press release contains "forward-looking statements,"
including statements relating to Lexicon's clinical development of
and regulatory filings for telotristat etiprate (LX1032) and the
results and projected timing of clinical trials and the potential
therapeutic and commercial potential of telotristat etiprate. In
addition, this press release also contains forward-looking
statements relating to Lexicon's growth and future operating
results, discovery and development of products, strategic alliances
and intellectual property, as well as other matters that are not
historical facts or information. All forward-looking statements are
based on management's current assumptions and expectations and
involve risks, uncertainties and other important factors,
specifically including the risk that clinical studies of
telotristat etiprate may be halted, delayed or otherwise not
demonstrate safety or efficacy, the risk that Lexicon's licensees
may be unable to file for regulatory approval of telotristat
etiprate with regulatory authorities outside of the United States in accordance with its
currently anticipated timelines, the risk that the FDA and other
regulatory authorities may not grant regulatory approval of
telotristat etiprate in accordance with Lexicon's currently
anticipated timelines or at all, and the risk that such regulatory
approvals, if granted, may have significant limitations on the
approved use of telotristat etiprate. As a result, telotristat
etiprate may never be successfully commercialized. Other risks
include Lexicon's ability to meet its capital requirements,
successfully conduct preclinical and clinical development and
obtain necessary regulatory approvals of its other potential drug
candidates, achieve its operational objectives, obtain patent
protection for its discoveries and establish strategic alliances,
as well as additional factors relating to manufacturing,
intellectual property rights, and the therapeutic or commercial
value of its drug candidates. Any of these risks, uncertainties and
other factors may cause Lexicon's actual results to be materially
different from any future results expressed or implied by such
forward-looking statements. Information identifying such important
factors is contained under "Risk Factors" in Lexicon's annual
report on Form 10-K for the year ended December 31, 2015, as filed with the Securities
and Exchange Commission. Lexicon undertakes no obligation to update
or revise any such forward-looking statements, whether as a result
of new information, future events or otherwise.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/lexicon-announces-fda-priority-review-of-new-drug-application-for-telotristat-etiprate-for-the-treatment-of-carcinoid-syndrome-300276716.html
SOURCE Lexicon Pharmaceuticals, Inc.